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Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells

Phase 1
Completed
Conditions
Glioblastoma
Cancer - Brain
Registration Number
ACTRN12605000423617
Lead Sponsor
Queensland Institute of Medical Research (QIMR)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
10
Inclusion Criteria

Confirmed Malignant Glioma, Macroscopic tumour resection, normal haematolological parameters, acceptable liver and renal function parameters.

Exclusion Criteria

Extensive intracranial disease precluding total or subtotal resection, ECOG status >2, History of autoimmune disease or immunosuppressive therapy, Prior use of immunotherapeutic agent, Positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Pregnancy, Other malignancy, Patients in whom only biopsy or partial resection was possible.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety[After each vaccine (fortnightly for 6 injections, then 6 weekly for 1 year.) Evaluations will also be performed within 6 weeks of the final vaccination and whenever clinically indicatedor until disease progression). Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.]
Secondary Outcome Measures
NameTimeMethod
Clinical efficacy based on the time interval between the first vaccination and disease progression.[Disease progression is assessed at vaccination (fortnightly for 6 injections, then 6 weekly for 1 year, within 6 weeks of the final vaccination and whenever clinically indicated. Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.]
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